Intro: Recent studies on colorectal cancer surgery have been focusing on the role of intestinal microbiome on surgical outcomes. Standard perioperative cares, like mechanic bowel preparation (MBP), administration of antibiotics (ABT) and surgery-related stress and injury influence the microbiome composition and possibly induce a shift toward a microbiome dysbiotic state, which predisposes to complicated postoperative course. Microbiome composition changes and enhanced virulence factors may increase the risk of postoperative complications, such as anastomotic leakage (AL), surgical site infection (SSI), and postoperative ileus (PI), which are known to impact on patient's overall survival and cancer recurrence.
Objective: The primary objective is to investigate if a significant association might exist between the microbiome composition and the occurrence of postoperative complications at 90 days.
Methods: 3 different microbiome samples will be taken from all patients. Two fresh fecal samples for detection of LM and fecal water preparation: a) a day before the surgery before MBP and/or ABT (LM1), b) postoperatively after first bowel movement (LM2). One sample will be taken intra-operatively from the stapled resection lines of circular stapler used for forming a colorectal anastomosis, to detect the MAM and to perform immunohistochemistry staining for detection of HACE1 expression.
DNA analysis will be performed for all samples. IHC will be performed for detecting HACE1 expression in the tumor and colorectal anastomosis tissues using anti-HACE1 antibodies. .
For proliferation assessment, human colon carcinoma cell lines HT29 will be plated in monolayers and scratched with a single scratch. Monolayers will be incubated for 24 hours with fecal water from patients with surgical complications and matched control patients without complications.
Descriptive statistics will be performed to describe the study population. This project aim to describe microbiome composition and its impact on postoperative complications.
Condition or disease |
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Adenocarcinoma of the Colon Adenocarcinoma of the Rectum |
Study Type : | Observational |
Estimated Enrollment : | 50 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery |
Actual Study Start Date : | May 28, 2019 |
Estimated Primary Completion Date : | April 1, 2020 |
Estimated Study Completion Date : | April 1, 2020 |
Group/Cohort |
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preoperative preparation on microbiome composition
Mechanical Bowel Preparation + oral antibiotics group: receiving mechanical bowel preparation only MBP will be prepared with 4 liters of Polyethylene glycol (PEG) solution to be started 24 hours before the planned surgery. 500mg of Metronidazole will be administrated 3 times one day before the surgery at 2 pm, 3 pm and 10 pm.
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Monolayers of human colon cancer cell lines HT29 will be incubated for 24 hours with fecal water from patients with surgical complications and matched control patients without complications.
Proliferation will be calculated in two manners: 1) The time of the closure of the scratch defect will be evaluated and compared in the two group., 2)Proliferation rate will be analyzed by immunohistochemistry marker Ki 67, expression of Ki 67 will be evaluated in cells at the borders of the scratch defect
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lelde Lauka, PHD | 01 49 81 41 74 ext +33 | lelde.lauka@aphp.fr |
France | |
Dr Lelde Lauka | Recruiting |
Créteil, France, 94000 | |
Contact: Lauka Lelde, PhD |
Principal Investigator: | Lelde Lauka, PHD | APHP |
Tracking Information | |||||
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First Submitted Date | March 15, 2019 | ||||
First Posted Date | July 2, 2019 | ||||
Last Update Posted Date | July 2, 2019 | ||||
Actual Study Start Date | May 28, 2019 | ||||
Estimated Primary Completion Date | April 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery | ||||
Official Title | Human Intestinal Microbiome and Surgical Outcomes in Patients Undergoing Colorectal Cancer Surgery | ||||
Brief Summary |
Intro: Recent studies on colorectal cancer surgery have been focusing on the role of intestinal microbiome on surgical outcomes. Standard perioperative cares, like mechanic bowel preparation (MBP), administration of antibiotics (ABT) and surgery-related stress and injury influence the microbiome composition and possibly induce a shift toward a microbiome dysbiotic state, which predisposes to complicated postoperative course. Microbiome composition changes and enhanced virulence factors may increase the risk of postoperative complications, such as anastomotic leakage (AL), surgical site infection (SSI), and postoperative ileus (PI), which are known to impact on patient's overall survival and cancer recurrence. Objective: The primary objective is to investigate if a significant association might exist between the microbiome composition and the occurrence of postoperative complications at 90 days. Methods: 3 different microbiome samples will be taken from all patients. Two fresh fecal samples for detection of LM and fecal water preparation: a) a day before the surgery before MBP and/or ABT (LM1), b) postoperatively after first bowel movement (LM2). One sample will be taken intra-operatively from the stapled resection lines of circular stapler used for forming a colorectal anastomosis, to detect the MAM and to perform immunohistochemistry staining for detection of HACE1 expression. DNA analysis will be performed for all samples. IHC will be performed for detecting HACE1 expression in the tumor and colorectal anastomosis tissues using anti-HACE1 antibodies. . For proliferation assessment, human colon carcinoma cell lines HT29 will be plated in monolayers and scratched with a single scratch. Monolayers will be incubated for 24 hours with fecal water from patients with surgical complications and matched control patients without complications. Descriptive statistics will be performed to describe the study population. This project aim to describe microbiome composition and its impact on postoperative complications. |
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Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples With DNA Description:
3 different microbiome samples will be taken from all patients. Two fresh fecal samples for detection of luminal microbiota (LM) and fecal water preparation: a) a day before the surgery before Mechanic Bowel Preparation (MBP) and/or antibiotics (ABT) (LM1), b) postoperatively after first bowel movement (LM2). One sample will be taken intra-operatively from the stapled resection lines of circular stapler used for forming a colorectal anastomosis, to detect the Mucosal Associated Microbiota (MAM) and to perform immunohistochemistry staining for detection of HACE1 expression.
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Sampling Method | Non-Probability Sample | ||||
Study Population | Patient with rectal or left colon adenocarcinoma | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | preoperative preparation on microbiome composition
Mechanical Bowel Preparation + oral antibiotics group: receiving mechanical bowel preparation only MBP will be prepared with 4 liters of Polyethylene glycol (PEG) solution to be started 24 hours before the planned surgery. 500mg of Metronidazole will be administrated 3 times one day before the surgery at 2 pm, 3 pm and 10 pm.
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Unknown status | ||||
Estimated Enrollment |
50 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | April 1, 2020 | ||||
Estimated Primary Completion Date | April 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04005118 | ||||
Other Study ID Numbers | APHP190088 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | Assistance Publique - Hôpitaux de Paris | ||||
Study Sponsor | Assistance Publique - Hôpitaux de Paris | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Assistance Publique - Hôpitaux de Paris | ||||
Verification Date | May 2019 |